Amantadine Versus Ritalin in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Amantadine VS Ritalin in the Treatment of ADHD: a Double Blind Randomized Trial

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01099059
• Other study ID #: 8630
• Status: Unknown status
• Phase: Phase 2
• First received: April 3, 2010
• Last updated: November 17, 2010
• Start date: April 2010
• Est. completion date: June 2010

Study information

• Verified date: November 2010
• Source: Tehran University of Medical Sciences
• Contact: Shahin Akhondzadeh, Ph.D.
• Phone: +98-21-88952510
• Email: s.akhond[@]nea.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Attention-deficit hyperactivity disorder (ADHD) is the most common neurobehavioural disorder of childhood. The investigators hypothesized that amantadine would be beneficial for treatment of ADHD, and this could be evaluated in a double blind, randomized, parallel group comparison of amantadine and ritalin.

This will be a six-week, parallel group, randomized clinical trial undertaken in an outpatient child and adolescent clinic at Roozbeh Psychiatric Hospital in Tehran, Iran during April 2010-May 2010.

50 male and female subjects, ages 6 to 17 years with a DSM-IV-TR diagnosis of ADHD will be study population of this trial. At screening, investigators conduct a psychiatric evaluation with the DSM-IV-TR criteria for ADHD and the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime diagnostic interview and perform a complete medical history and physical examination.

The diagnosis of ADHD will be confirmed by a child and adolescent psychiatrist before participants will be initiated into the study. All patients will be newly diagnosed. Parents were carefully interview and ask to rate the severity of the DSM-IV-TR ADHD symptoms that their children display at home. Children will be excluded if they have a history or current diagnosis of pervasive developmental disorders, schizophrenia or other psychiatric disorders(DSM-IV axis I); any current psychiatric comorbidity that required pharmacotherapy; any evidence of suicide risk and mental retardation (I.Q. <70). In addition, patients will be excluded if they have a clinically significant chronic medical condition, including organic brain disorder, seizures and, current abuse or dependence on drugs within 6 months. Additional exclusion criteria will be hypertension, hypotension. To participate, parents and children have to be willing to comply with all requirements of the study. After a description of the procedures and purpose of the study, written informed consent will be obtained from each patient's parent or guardian. Informed consent will receive before the administration of any study procedure or dispensing of study medication in accordance with the ethical standards of the investigative site's institutional review board and with the Helsinki declaration of 1975, as revised in 2000. The protocol will be approved by the Institutional Review Board (IRB) of Tehran University of Medical Sciences.

Patients will be randomized to receive amantadine or ritalin in a 1: 1 ratio using a computer-generated code.

All study subjects will be randomly assigned to receive treatment using amantadine 100-150 mg depending on weight (100 mg/day for <30 Kg and 150 mg/day for >30 Kg) or ritalin at a dose of 20-30 mg/day depending on weight (20 mg/day for <30 Kg and 30 mg/day for >30 Kg) (group 2) for a 6 week double blind, randomized clinical.

The principal measure of outcome will be the Parent and Teacher ADHD Rating Scale-IV that has been used extensively in Iran in school-age children and provides valid measures of behavioral abnormality and attention trial.

Side effects will be systematically recorded throughout the study and will be assessed using a checklist that comprises 20 side effects including psychic, neurologic, autonomic and other side effects, administered by a child psychiatrist on days 7, 21and 42.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 40
• Est. completion date: June 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

• 50 male and female subjects, ages 6 to 17 years with a DSM-IV-TR diagnosis of ADHD will be study population of this trial. At screening, investigators conduct a psychiatric evaluation with the DSM-IV-TR criteria for ADHD and the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime diagnostic interview and perform a complete medical history and physical examination.

Exclusion Criteria:

• Children will be excluded if they have a history or current diagnosis of pervasive developmental disorders, schizophrenia or other psychiatric disorders(DSM-IV axis I)

• Any current psychiatric comorbidity that required pharmacotherapy

• Any evidence of suicide risk and mental retardation (I.Q. <70).

• In addition, patients will be excluded if they have a clinically significant chronic medical condition, including organic brain disorder, seizures and, current abuse or dependence on drugs within 6 months.

• Additional exclusion criteria will be hypertension, hypotension.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Amantadine
Amantadine 100-150 mg depending on weight (100 mg/day for <30 Kg and 150 mg/day for >30 Kg)
• ritalin
ritalin at a dose of 20-30 mg/day depending on weight (20 mg/day for <30 Kg and 30 mg/day for >30 Kg)

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean decrease in ADHD -RS-IV score from baseline will be used as the main outcome measure of response of ADHD treatment.	ADHD-RS-IV is an instrument that assesses the 18 symptoms of ADHD as defined in the DSM-IV-TR according to a 4-point Likert scale.	6 weeks